Senior Quality Control Technician I

Takeda•Social Circle, GA

4d•Onsite

About The Position

You will conduct and perform a wide range of biological, chemical, and physical analyses. These analyses are performed on pharmaceutical products, including biologics and drugs, through all stages of the manufacturing process. This process spans from incoming raw materials to finished goods. Additionally, the role may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations.

Requirements

Typically requires bachelors' degree in science, engineering or other related technical field.
In lieu of degree, (5+) years of related experience in a GMP environment.
Proficient in wet and instrumental methods of analyses.
Advanced laboratory skills and basic knowledge of statistical method.
Must communicate effectively (verbal and written) with supervisors and peers.
Must demonstrate effectiveness in ability to train others
Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.
Must be proficient in multiple mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
Will read and follow detailed written instructions and have good verbal/written communication skills.
Knowledge of basic chemical and biological safety procedures.
Computer skills, knowledge of Microsoft Word, Excel and PowerPoint

Nice To Haves

Bachelors' Degree in Chemistry or Biological Science is ideal

Responsibilities

Collect samples from manufacturing areas to evaluate environmental classification or critical utility integrity.
Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at the company manufacturing facilities.
Use laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
Complete all testing, including special project/protocol testing.
Initiate and obtain applicable approval for test requests.
May maintain inventory/supplies necessary to conduct routine testing.
Follow continuous improvement practices (QLP, 5S, LEAN)
Perform equipment maintenance and calibrations.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
Perform release functions in LIMS or other computerized systems.